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Trial registered on ANZCTR


Registration number
ACTRN12619001469101
Ethics application status
Approved
Date submitted
5/07/2019
Date registered
23/10/2019
Date last updated
23/10/2019
Date data sharing statement initially provided
23/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Gait training in patients at an early stage post-stroke – a randomised pilot study
Scientific title
Assessment of automatic-walker-aided gait training in patients at an early stage post-stroke – a randomised pilot study
Secondary ID [1] 298527 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 313337 0
gait limitations 313338 0
Condition category
Condition code
Stroke 311830 311830 0 0
Ischaemic
Stroke 311831 311831 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 312763 312763 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program includes a series of gait training sessions with the use of an automatic walker Reha Trainer. During the rehabilitation program, participants qualified in a group with intervention (using THERA-Trainer E-GO) will participate in 15 sessions, for the next three weeks, every day from Monday to Friday. Each training session will last 45 minutes including device fit and rest periods. The effective walk time will not be less than 30 minutes per workout. All trainings will be conducted in the Rehabilitation Clinic (obstacle-free hall). Walking training will consist of walking straight ahead (25 meters), turning back (alternating right and left) and walking in the opposite direction in a straight line.
The walking speed will be adjusted to the patient's capabilities and will gradually increase in subsequent workouts. The individual gait rate achieved in the initial 10 metre walk test, will be increased by 0.05 m/s per day from 2 session.
The walking exercise will be supervised by experienced physiotherapists with training in the use of the device. Each training session will be monitored and documented.
Intervention code [1] 314816 0
Treatment: Devices
Intervention code [2] 314817 0
Rehabilitation
Comparator / control treatment
The subjects in the control group will take part in gait exercise program based on partial body-weight-support treadmill training. Like in the case of the intervention group their gait training will continue for three weeks, 15 sessions, 45 minutes each. The subjects in the control group receiving conventional physiotherapy for three weeks, will on a daily basis (15 sessions) take part in 30-minute therapy oriented toward gait re-education. All the subjects, patients of a Rehabilitation Clinic, will take part in a daily rehabilitation program for 150 minutes per day, including 60 minutes of individual physiotherapy, in addition to the program defined in connection with the study.
Control group
Active

Outcomes
Primary outcome [1] 320502 0
The basic outcome measure will be the difference in the walking speed between the intervention group and the controls, assessed with 10-metre walk test performed with normal speed.
Timepoint [1] 320502 0
Baseline, before program and after 3 weeks treatment with THERA-Trainer E-GO
Primary outcome [2] 320503 0
Gait independence will be assessed according to Functional Ambulation Category (FAC).
Timepoint [2] 320503 0
Baseline, before program and after 3 weeks treatment with THERA-Trainer E-GO
Secondary outcome [1] 371829 0
Trunk control will be assessed with Trunk Control Test (TCT).
Timepoint [1] 371829 0
Baseline, before program and after 3 weeks treatment with THERA-Trainer E-GO
Secondary outcome [2] 371830 0
Independence in activities of daily living was assessed using Barthel index.
Timepoint [2] 371830 0
Baseline, before program and after 3 weeks treatment with THERA-Trainer E-GO

Eligibility
Key inclusion criteria
Inclusion criteria: ischemic stroke, time from stroke onset up to three months, ability to stand and walk independently with a speed up to 0.2 m/s, motor control of the affected lower limb not higher that Brunnstrom stage 3, consent for participation in the study.
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: second or another stroke, reported incident of severe heart failure and uncontrolled arterial hypertension, cognitive disorders impairing the understanding of and ability to follow instructions, visual field disturbances caused by a stroke or other visual disturbances impairing normal vision, orthopaedic disorders significantly affecting the subjects’ gait, and untreated deep vein thrombosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
2-arm trial
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21628 0
Poland
State/province [1] 21628 0
Podkarpackie

Funding & Sponsors
Funding source category [1] 303073 0
University
Name [1] 303073 0
University of Rzeszow
Address [1] 303073 0
University of Rzeszow
Aleja Rejtana 16c
35-959 Rzeszow
Country [1] 303073 0
Poland
Primary sponsor type
Hospital
Name
St. Quenn Jadwigas Regional clinical Hospital nr. 2 in Rzeszow, Poland
Address
ul. Lwowska 60,
35-301 Rzeszów, Poland
Country
Poland
Secondary sponsor category [1] 303056 0
None
Name [1] 303056 0
Address [1] 303056 0
Country [1] 303056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303621 0
Bioethics Committee at University of Rzeszow
Ethics committee address [1] 303621 0
Al. Kopisto 2a
35-959 Rzeszów
email: komisjabioetur@gmail.com
Ethics committee country [1] 303621 0
Poland
Date submitted for ethics approval [1] 303621 0
11/12/2018
Approval date [1] 303621 0
10/01/2019
Ethics approval number [1] 303621 0
Decision Nr 6/12/2016

Summary
Brief summary
The purpose of the randomised pilot study will be to show whether gait training with the walker leads to better improvement in gait speed and independence, as compared to treadmill training with partial body weight support system. This is an introductory study which firstly is to answer whether theoretical assumptions will be confirmed during practical application, and secondly is to enable improvement in gait training and in assessment methodology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94290 0
A/Prof Mariusz Druzbicki
Address 94290 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 94290 0
Poland
Phone 94290 0
+48178721941
Fax 94290 0
+48178721930
Email 94290 0
mdruzb@ur.edu.pl
Contact person for public queries
Name 94291 0
A/Prof Mariusz Druzbicki
Address 94291 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 94291 0
Poland
Phone 94291 0
+48178721941
Fax 94291 0
+48178721930
Email 94291 0
mdruzb@ur.edu.pl
Contact person for scientific queries
Name 94292 0
A/Prof Mariusz Druzbicki
Address 94292 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 94292 0
Poland
Phone 94292 0
+48178721941
Fax 94292 0
+48178721930
Email 94292 0
mdruzb@ur.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results